echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > First! Mylan Tecfidera generics are approved by the FDA.

    First! Mylan Tecfidera generics are approved by the FDA.

    • Last Update: 2020-08-30
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Recently, the U.S. FDA approved the first generic drug of Tecfidera, the best-selling multiple sclerosis drug.
    despite his great efforts to defend the Tecfidera patent, Mylan cleared the hurdles and was eventually approved.
    120mg and 240mg doses of the Tecfidera generic, marking the first oral generic for multiple sclerosis in U.S. patients,
    said in a statement.
    's approval of the Tecfidera generics was the result of Mylan's victory in a lawsuit filed in the U.S. District Court for the Northern District of West Virginia, which invalidated the Tecfidera patent, paving the way for mylan's generic approval to go public.
    conference call last month, Michel Vounatsos, chief executive, said he was "disappointed" by the ruling and would vigorously defend Tecfidera's intellectual property rights.
    , He said he would appeal, meaning the future of Mylan generics could be uncertain as the appeal progresses.
    if Mr. Yan wins the appeal, Mr. Mylan could be forced to pay huge damages.
    a client, Michael Yee, an analyst at Jefferies, wrote that the launch of mylan generics "adds new uncertainty" to the future of Tecfidera.
    Tecfidera generated $1.18 billion in revenue in the second quarter of 2019 alone, or about 32 percent of its total revenue, according to IQVIA.
    the loss of exclusive patent rights, Yan Jian had to step up the development of a new oral reprimbly capsule, Vumerity, but the drug generated only $9 million in revenue in the second quarter.
    addition to this, Yan Jian has also been hit by generic drugs in other areas.
    Spinraza is the company's best-selling drug after Tecfidera, which now faces competition from Roche Evrysdi.
    sources: 1, Mylan Wins Approval for First Generic to Biogen's MS Drug Tecfidera 2, Mylan's Tecfidera Generic launch jolts Biogen, point at stake.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.